Oct 7, 2016 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
Startup medical company proposes to offer free genetic testing to 100,000 advanced cancer patients to increase their chances for optimum therapeutic results
Strata Oncology (Strata), a precision medicine company based in Ann Arbor, Mich., plans to provide free genetic testing to advanced cancer patients beginning in 2017. The company raised $12-million dollars and teamed up with Thermo Fisher Scientific to complete the large-scale tumor sequencing project.
Using tumor tissue, Strata’s gene test sequences DNA and RNA to identify patients with certain gene mutations. This information is used to determine which cancer medications would be best for each patient. Patients are then referred to the appropriate pharmaceutical company for drug therapy and, potentially, for customized clinical trials.
Strata states on their website that their goal is to “dramatically expand late-stage cancer patients’ access to tumor sequencing and precision medicine trials, and to accelerate the approval and availability of breakthrough cancer medicines.” (more…)
Sep 23, 2016 | Laboratory Hiring & Human Resources, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
Hood predicts US healthcare spending will drop in the coming years as genome sequencing becomes routine for hospital patients and big data leads to advancements in disease prevention
Systems biology is a field of scientific research that has the potential to provide plenty of new biomarkers that could be used by clinical laboratories to detect disease earlier and with more accuracy and to guide physicians on how to treat disease. Now comes news of a unique collaboration designed to use knowledge of systems biology in ways that can advance clinical care.
The Institute for Systems Biology (ISB) recently teamed up with Providence Health & Services (Providence) to advance the mission of ISB’s President and co-founder Leroy Hood, MD, PhD, to transform healthcare through “Scientific Wellness.”
Pathologists and clinical laboratory managers will want to note this new partnership. That’s because ISB’s end-goal is the pre-symptomatic diagnosis of disease using multiplex assays to pinpoint protein biomarkers that signal the presence of disease. (more…)
Aug 19, 2016 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Pathology, Laboratory Testing
High-powered hand dryers, like the ones used in public restrooms, are the latest pawns in the relentless pursuit to repulse individuals fixated on cleanliness
For decades, microbiologists have regularly fanned out in hospitals and swabbed the hands of doctors, nurses, and staff, to demonstrate how often infectious agents get passed on to patients through interactions with their caregivers (due to lack of proper handwashing procedures prior to entering a patient’s hospital room, for example). One thing that was a regular on these fishing expeditions was to swab the ties worn by physicians and report on the interesting and disturbing array of infectious agents that were found.
Well, the microbiologists are at it again! After studying hand drying techniques, researchers at The University of Westminster in London determined that high-powered jet air dryers can act like “virus hand grenades.” (more…)
Aug 17, 2016 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology
Powered by massive data sets, precision medicine is unlocking new insight into the treatment of diseases and conditions. At the same time, pathology groups and medical laboratories are leading the way to creating the storage solutions, analytic tools, and networks that will power tomorrow’s advances in precision medicine
There is exponential growth in the amount of data generated at medical laboratories, pathology groups, and hospital diagnostic facilities. As gene sequencing technologies and tools continue to decrease in price but increase in both speed and accessibility, the volume of data will grow further still.
This has major implications for the field of precision medicine. In order for physicians, hospitals, and clinical laboratories to move forward with precision medicine, to advance, it will be essential that they have sophisticated capabilities in data handling, storage, and analysis.
Yet, hospitals wanting to do more with precision medicine might not be the providers that unravel the technicalities of harnessing this new pool of big data. Pathology groups and medical laboratories are already familiar with the challenges of managing complex data, such as that created by genome sequencing and molecular diagnostic assays. As they continue to bolster their information technology (IT) staffing and infrastructure, these labs are positioned to be the keepers for much of the data driving new medical developments.
Hospital IT Departments Lag in Preparations to Handle Genomic Data
In a Health Catalyst survey, 59% of healthcare executives polled do not believe that precision medicine will play a significant role in their organizations by 2020. Nearly two-thirds of respondents have no plan to integrate genomic data into their electronic health record (EHR) systems.
Despite the trend against genomic data integration, the same survey noted that half of the respondents believe that DNA sequencing could improve patient treatment strategies within their organizations.
However, as medical laboratories have known for some time, obtaining data from molecular and genetic testing is only the beginning. Without the ability to analyze results, communicate information, and store lab test data for access by other parties, the potential benefits of precision medicine will remain unrealized.
Medical Laboratories Leading the Charge for Better Data Handling and Analysis
The good news is that within many health systems, medical laboratories are already adapting IT systems to manage the large data sets required for molecular diagnostics and genetic testing. One of the lessons these labs are learning is that the more molecular and genetic testing the do, the more informatics staff they need.
Simply said, these innovative labs are devoting more physical space to informatics and a larger proportion of the laboratory staff are informatics specialists. In The Dark Report, Gregory J. Tsongalis, PhD, Professor of Pathology and Director of Molecular Pathology at the Theodore Geisel School of Medicine at Dartmouth College, stated, “We just opened a new clinical lab facility of 11,000 square feet at the Geisel School. Over 25% of that space will be devoted to data management. Because of the increasing volume of data generated at this site, there are more computational technologists than lab technicians.” (See The Dark Report, “New Molecular Analyzers to Bring Big Data to All Labs, July 13, 2015.)
Gregory J. Tsongalis, PhD (center right), is Professor of Pathology and Director of Molecular Pathology at the Theodore Geisel School of Medicine at Dartmouth College. (Photo copyright: The Geisel School of Medicine at Dartmouth.)
Tsongalis believes that labs themselves are positioned to become the storage providers and gatekeepers for much of the data driving precision medicine. Noting an increasing shift toward staffing informaticists in clinical labs to handle data, he says, “This is probably one aspect of the big data trend where pathologists and lab scientists are ahead of health system administrators.”
Medical Labs Must Address Issues Associate with Handling Genomic Data
Regardless of who holds the increasing amount of genomic data coming out of assays and tests, healthcare providers, laboratories, and vendors must create a set of standards to address both integration with EHR systems, and maintaining privacy and security on a scale never-before addressed.
In an article published in Health Data Management, Deven McGraw, Deputy Director for Health Information Privacy at the Department of Health and Human Services Office for Civil Rights, stressed the importance of data security as the regulatory agency begins work on aspects of the Precision Medicine Initiative. “A robust data security framework will be built in from the start. This is a new model for scientific research, but it is not widespread,” McGraw stated.
The Action Collaborative on Developing Guiding Principles for Integrating Genomic Information into the Electronic Health Record Ecosystem also is piloting a collaborative between Intermountain Healthcare, ARUP Laboratories, and Cerner, to examine privacy standards as well as standards for integration and representation of genomic data sets.
As pools of healthcare data and medical laboratory test results continue to grow and clinical laboratories continue to explore new methods of genetic testing and analysis, partnerships such as the Action Collaborative will remain critical opportunities for medical laboratories and pathology groups to use their current advantage to further their future roles in precision medicine.
—Jon Stone
Related Information:
Survey: Most Healthcare Organizations Unprepared for Precision Medicine
Big IT Challenges Ahead for Precision Medicine
About the Precision Medicine Initiative Cohort Program
Fact Sheet: President Obama’s Precision Medicine Initiative
DIGITizE: Displaying and Integrating Genetic Information Through the EHR
Newer, Smaller Analyzers Will Bring Big Data to Labs
Jun 10, 2016 | Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Some cancer researchers worry that these patients may not benefit from such clinical laboratory testing because effective therapeutic drugs don’t exist for their cancers
What can be more patient-centric than for a medical laboratory company to offer free genetic tests for cancer? That’s the strategy of a firm in Canada that is offering free cancer genomics testing to 1,500 cancer patients. However, some cancer researchers responded to this offer with skepticism.
In March, Contextual Genomics of Vancouver, British Columbia, began providing its cancer genomics test free to the first 1,500 patients whose oncologists submitted tumor samples. These specimens would be tested using the company’s Find It hotspot cancer panel.
“You could call it marketing, but it’s making this test available to people who haven’t had access to it before,” stated Chris Wagner, Contextual Genomics President and CEO, in a CBC News Canada interview.
Contextual Genomics says its Find It test focuses on “90 hotspots across 29 known cancer genes and analyzes seven exons of three genes,” with the specific genes and mutations selected because they are “actionable and can potentially direct patient treatment, indicate prognosis, and support diagnosis.” Oncologists that participate in this commercial pilot program will receive a comprehensive report that interprets the sequencing results. The report also identifies any approved drugs or clinical trials that target the patient’s gene mutations. (more…)
